NCT03425162

Brief Summary

Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain, despite a multimodal analgesic regime. This is a randomised controlled trial efficacy of the anterior Quadratus Lumborum Block (QLB) in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

February 1, 2018

Last Update Submit

November 20, 2018

Conditions

Keywords

quadratus lumborum blockpainultrasoundpercutaneous nephrolithotomy

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)

    Postoperative 24 hours

Secondary Outcomes (3)

  • morphine consumption

    Postoperative 24 hours

  • side effect profile

    Postoperative 24 hours

  • additional analgesic use

    Postoperative 24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 bupivacaine+PCA (morphine)

Drug: Morphine SulfateProcedure: Group A

Group P

SHAM COMPARATOR

Group P:PCA (morphine)

Drug: Morphine SulfateProcedure: Group P

Interventions

patient-controlled analgesia (PCA) morphine

Also known as: Morphine
Group AGroup P
Group PPROCEDURE

Group P:patient-controlled analgesia (PCA) morphine

Group P
Group APROCEDURE

Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 Bupivacaine

Also known as: Bupivacaine
Group A

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent elective Percutaneous nephrolithotomy

You may not qualify if:

  • Previous history of opioid use preoperatively,
  • Allergy to local anesthetics,
  • The presence of any systemic infection,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

MorphineBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Korgün Ökmen, M.D

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective,randomized,single blind
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 7, 2018

Study Start

February 12, 2018

Primary Completion

August 18, 2018

Study Completion

August 18, 2018

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations